BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Cochlear

    PMA: P000025 · Supplement: S098 · Decision Apr 20, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Implant, Cochlear
    Trade Name
    MED-EL Cochlear Implants
    PMA Number
    P000025
    Supplement Number
    S098
    Device Class
    FDA Class 3
    Product Code
    MCM
    Generic Name
    Implant, cochlear
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 20, 2018
    Date Received
    January 22, 2018
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the following changes to the Medical Procedures Manual (MPM) AW33290 EN US of the labeling: 1) Change to allow diagnostic ultrasound exposure for MED-EL Cochlear Implants;2) Changes related to MRI (MPM section "Magnetic Resonance Imaging (MRI) Safety Information");3) Addition of some introductory text;4) Correction of MRI condition for SONATA and Mi1000 CONCERT (PIN); and5) Editorial changes.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MCM Implant, Cochlear